510(k) clearances

Premarket notifications cleared by FDA, newest decision first.

Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.

Data as of 2026-10-26, the FDA export date. FDA 510(k) database

Clearances by decision year

Last 15 years

46,069 of the 176,466 ingested clearances have a decision year between 2012 and 2026, the 15 years shown, 2023 the highest year at 3,346.

Show the numbers

510(k) clearances by decision year, the last 15 years of ingested records
Year	Clearances
2012	3,135
2013	3,052
2014	3,202
2015	3,020
2016	2,956
2017	3,200
2018	3,062
2019	2,918
2020	2,923
2021	3,023
2022	3,209
2023	3,346
2024	3,129
2025	3,225
2026	2,669

176,466 records, page 768 of 3530

510(k) clearances, page 768 of 3530
K number	Device	Applicant	Product code	Class	Decision date
K141104	Truklear Bracket	Ajw Technology Consultants, Inc.	NJM	Class II	2014-06-25
K140801	Variant II Turbo Link Hemoglobin A1c Program/testing System	Bio-Rad Laboratories Inc.	LCP	Class II	2014-06-25
K140629	Venus Swan(mp)2	Venus Concept Inc.	GEI	Class II	2014-06-25
K140336	Optimus Fusion: Slt, Yag and Yag/slt	Quantel Medical	HQF	Class II	2014-06-25
K140188	Masimo Root Monitoring System	Masimo Corporation	MWI	Class II	2014-06-25
K133848	Rthawk, Rthawk, or Heartvista Workstation with Rthawk	Heartvista, Inc.	LNH	Class II	2014-06-25
K133327	Saturno(tm) Overdenture Implant System	Zest Anchors LLC	DZE	Class II	2014-06-25
K132333	Bondiloxs Topical Hemostatic Dressing	Medtrade Products Ltd.	QSY	Unclassified	2014-06-25
K132180	Ideal Life Gluco-Manager Blood Glucose Monitoring System	Ideal Life, Inc.	NBW	Class II	2014-06-25
K132115	Absolute Dentin 2	Parkell, Inc.	EBF	Class II	2014-06-25
K140660	Mobius3d	Mobius Medical Systems, LP	IYE	Class II	2014-06-24
K133816	Immulite 2000 Free Psa Calibration Verification Material	Siemens Healthcare Diagnostics Inc.	JJX	Class I	2014-06-24
K133105	Breeze Nebulizer (Nbr-10X)	Digio2 International Co., Ltd.	CAF	Class II	2014-06-24
K133083	Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set	Diazyme Laboratories, Inc.	DBF	Class II	2014-06-24
K141232	Aptus Ulna Shortening 2.5	Medartis AG	HRS	Class II	2014-06-23
K141073	Liquichek Tumor Marker Control	Bio-Rad Laboratories Inc.	JJY	Class I	2014-06-23
K141072	Supolene	RESORBA Medical GmbH	GAT	Class II	2014-06-23
K140809	Cliq Dv-300 Aspirator	Ding Hwa Co., Ltd.	JCX	Class II	2014-06-23
K133193	Rs Orange Nitrile Medical Examination Gloves (Powder Free)	Riverstone Resources Sdn Bhd	LZA	Class I	2014-06-23
K131416	Novopress	Milka, LLC	JOW	Class II	2014-06-23
K130265	Contour Next Ez Blood Glucose Meter	Medrad, Inc.	NBW	Class II	2014-06-23
K141356	Echo Tip Ultra Fiducial Needle	Wilson-Cook Medical Inc.	NEU	Class II	2014-06-20
K141329	Radspa	Telerad Tech Private Limited	LLZ	Class II	2014-06-20
K141204	Variax 2 One Third Tubular Plating System	Stryker Trauma GmbH	HRS	Class II	2014-06-20
K141199	Quentry Dose Review	Brainlab, Inc.	LLZ	Class II	2014-06-20
K141149	Vitek 2 Ast Gp Ceftaroline	bioMerieux, Inc.	LON	Class II	2014-06-20
K141121	Axsos 3 Ti Locking Plate System	Stryker Trauma GmbH	HRS	Class II	2014-06-20
K140711	Comfortear Lacrisolve Absorbable Punctum Plug, Lacrisolve Absorbable Punctum Plug, Comfortear Lacrisolve Punctum Plug,	Paragon Bioteck, Inc.	LZU	Unclassified	2014-06-20
K140679	Sureflex Lithotripsy Laser Fibers	American Medical Systems, Inc.	GEX	Class II	2014-06-20
K140610	Nitrile Powder Free Examination Glove - Aqua Blue (Ablu) / Violet Blue (Vblu) / Dark Blue (Dkbu)	Hartalega NGC Sdn Bhd	LZA	Class I	2014-06-20
K140278	Somnodent Fusion, Classic; Somnodent Fusion, Flex	Somnomed Inc.	LRK	Class II	2014-06-20
K140155	Secure-Gard Surgical and Procedure Face Mask	Cardinal Health200, LLC	FXX	Class II	2014-06-20
K140083	Verigene Enteric Pathogen Nucleic Acid Test ( Ep)	Luminex Corporation	PCH	Class II	2014-06-20
K134032	Ulthera System	Merz North America, Inc.	OHV	Class II	2014-06-20
K133886	Perseus A500	Draeger, Inc.	BSZ	Class II	2014-06-20
K133799	Thermedx Fluid Managment System	Thermedx LLC	HIG	Class II	2014-06-20
K133646	Admire	Siemens Medical Solutions USA, Inc.	JAK	Class II	2014-06-20
K133147	Bracco Injeenering Transfer Set	Bracco Injeneering S.A.	PQH	Class II	2014-06-20
K133062	Discovery System	Innovative Visual Systems	HJO	Class II	2014-06-20
K133011	Diaphragmatic Hernia Graft	Cook Biotech, Inc.	OWV	Class II	2014-06-20
K132697	Encompass 10/12 Hip Stem	Ortho Development Corp.	LPH	Class II	2014-06-20
K132489	Inogen at Home Oxygen Concentrator (Aka Inogen at Home)	Inogen, Inc	CAW	Class II	2014-06-20
K123149	Servo-I Ventilator System	Maquet Critical Care AB	CBK	Class II	2014-06-20
K140937	Osseoflex Sb	Osseon, LLC	NDN	Class II	2014-06-19
K140678	Cosmolock Pedicle Screw System	Kalitec Direct, LLC	MNH	Class II	2014-06-19
K140644	Procem	Ototronix, LLC	NEA	Class II	2014-06-19
K140510	Miromatrix Wound Matrix	Miromatrix Medical, Inc.	KGN	Unclassified	2014-06-19
K140370	Disposable Pressure Manometer	Besmed Health Business Corporation	CAP	Class II	2014-06-19
K133258	Trufreeze System	CSA Medical	GEH	Class II	2014-06-19
K133129	Abbvie Nj	AbbVie Inc	KNT	Class II	2014-06-19